The following data is part of a premarket notification filed by World Class Technology Corporation with the FDA for Clear21.
Device ID | K192202 |
510k Number | K192202 |
Device Name: | Clear21 |
Classification | Bracket, Ceramic, Orthodontic |
Applicant | World Class Technology Corporation 1300 NE Alpha Dr. Mcminnville, OR 97128 |
Contact | Alan Kozlowski |
Correspondent | Alyssa Thomas Allegiance Regulatory Consulting LLC 16642 SW Lansford Ct. Beaverton, OR 97007 |
Product Code | NJM |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-14 |
Decision Date | 2019-11-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CLEAR21 88318941 not registered Live/Pending |
World Class Technology Corporation 2019-02-27 |